Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.

FDA DeterminedCause 2

DESIGN: Device Design

Action

The firm, Bard Peripheral Vascular, sent a "Urgent: Medical Device Recall Notification" letter dated September 30, 2013 via FedEx to all the customers who received the specific lots on recall. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to fill out the Recall and Effectiveness Check Form and fax to: BPV at 1-800-994-6772, even if you no longer have possession of the recalled product; call Bard Peripheral Vascular's Recall Coordinator at (800) 321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email silvia.carrillo@crbard.com. The Recall Coordinator will issue you either a Return Authorization (RCL) Number or Consignment Recall Number (CRC) to facilitate the expedient return of the product; and to return the product to Bard Peripheral Vascular, Inc.,1415 W. 3rd Street,Tempe, AZ 85281. BPV will provide replacement product for your returned product.
If you have any questions, call 1-800-321-4254 Option #2 Ext. 2727.